Diabetes management using a clinical guideline versus usual practice: a feasibility trial-based qualitative study among Ayurvedic practitioners and patients in Nepal

TL;DR

A study in Nepal explored how Ayurvedic doctors and patients experienced managing diabetes with a new clinical guideline versus usual practice, finding the guideline approach more beneficial.

Contribution

The study developed and tested a clinical guideline for managing diabetes in Ayurvedic practice, a novel approach in Nepal.

Findings

The evidence-based clinical guideline for diabetes was well-received and seen as more beneficial than usual practice.

Participants identified challenges in trial conduct, including recruitment and documentation, which need addressing in future studies.

Abstract

Type 2 diabetes mellitus (T2DM) is common in Nepal, where many people seek primary care through Ayurveda, a widely practiced traditional medical system. However, concerns remain about variability in clinical practice and the quality of care provided by Ayurvedic practitioners. No evidence-based clinical practice guideline (EB-CPG) currently exists for managing T2DM in Ayurveda. To address this, an EB-CPG was developed, and a feasibility trial was conducted to inform a future definitive cluster randomized controlled trial evaluating whether the EB-CPG would improve T2DM management compared to usual clinical practice.

To explore the experiences and perspectives of Ayurvedic practitioners and patients regarding the two treatment groups (EB-CPG-based care versus usual clinical practice) and participation in the feasibility trial.

Constructivist qualitative study.

Semistructured interviews were conducted with Ayurvedic practitioners and patients. Data were analyzed thematically using an inductive approach and the framework method.

A total of 41 Ayurvedic practitioners and patients were interviewed. Common themes identified across both groups included facilitators and challenges in the trial patient recruitment, challenges in usual clinical care, experiences with EB-CPG-based care (predominantly positive), ease and difficulties of monthly follow-ups, and pros and cons of patient diaries for assessing medication compliance. Practitioner-specific themes included the diverse populations they serve; patients’ motivations for choosing Ayurveda over Western medicine; their motivations for trial participation; balancing clinical duties with the trial demands; confusion about trial roles and responsibilities; and other trial-related issues such as understanding processes and documentation, support and communication, coordination with data collectors, and finances and other resources.

The EB-CPG-based approach for managing T2DM by Ayurvedic practitioners in Nepal was well-received and perceived as more beneficial than usual clinical practice. Trial experiences and perspectives were largely positive; however, several challenges related to trial conduct should be addressed in future studies, including the definitive cluster trial.

Managing diabetes with or without a clinical guideline: views of Ayurvedic doctors and patients from a feasibility trial in Nepal

Type 2 diabetes is a common health problem in Nepal. Many people seek treatment through Ayurveda, a traditional system of medicine. However, there is no guideline to help Ayurvedic doctors manage diabetes, and the care provided can vary widely. To help improve care, researchers developed a clinical guideline based on the best available scientific evidence. They then ran a feasibility trial to help plan a larger study that will test whether the guideline improves diabetes management compared to usual practice. This study explored what Ayurvedic doctors and patients thought about the two types of care used in the feasibility trial: one based on the new guideline and the other following usual practice. Researchers also wanted to understand their experiences of taking part in the trial. Researchers interviewed 41 participants, including both doctors and patients. Key findings included what helped or made it difficult to recruit patients into the feasibility trial, challenges with usual care, mostly positive views about care based on the new guideline, ease and difficulties of monthly follow-up visits, and the pros and cons of using patient diaries to record medicine use. Doctors also talked about the wide range of patients they treat, why people choose Ayurveda over Western medicine, and their own reasons for joining the trial. They discussed challenges such as balancing regular duties with the trial work, confusion about their roles, understanding procedures and paperwork, communication and coordination, and access to support and resources. In conclusion, the new guideline-based approach for managing diabetes by Ayurvedic doctors in Nepal was well-received and seen as more helpful than usual care. Most experiences of the feasibility trial were positive, but some challenges in how the trial was carried out were identified. These should be addressed in future studies, including the planned larger trial.

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Introduction

Type 2 diabetes mellitus (T2DM) is a prevalent chronic condition that imposes a significant health and socioeconomic burden worldwide.^1,2^ Chronic hyperglycemia in this complex metabolic disorder is associated with a range of complications, including both macrovascular and microvascular damage, reduced health-related quality of life, and even premature death.^1,2^ In Nepal, the prevalence of T2DM increased from approximately 8% during 2010–2015 to 11% during 2015–2020.^ 3 ^ This figure is likely an underestimate, as many individuals remain undiagnosed due to the often asymptomatic nature of T2DM in its early stages.^ 4 ^ The rising burden of T2DM in Nepal contributes to increased morbidity and mortality and places significant strain on the health system, including higher service demand, escalating costs, and already strained infrastructure and limited workforce capacity. Weak primary care further exacerbates these challenges, leading to delayed diagnosis, increased risk of complications, and greater reliance on secondary and tertiary care services.^5,6^

Ayurveda, the dominant traditional medical system in Nepal, has been used for thousands of years for primary healthcare needs.^ 7 ^ Today, qualified and registered Ayurvedic practitioners are integral to public and private healthcare systems, often serving as primary clinical providers in Ayurveda centers.^7,8^ The basic principle of T2DM treatment is the same in Western and Ayurvedic medical systems: a combination of a healthy lifestyle and medicinal products.^ 9 ^ T2DM is one of the most common conditions for which individuals seek Ayurvedic care, and many people use Ayurvedic medicines containing ingredients of plant, animal, or mineral origin, either singly or in combination, consistently from the time of diagnosis.^8,10^ The main reasons for this include cultural health beliefs and a preference for avoiding side effects, costs, and administration modes associated with Western medicine (such as insulin injections), particularly among rural, impoverished, older, and Indigenous populations, and limited availability of Western medicine clinicians in rural areas.^10????–15^

Although systematic reviews of clinical trials have shown the effectiveness and safety of Ayurvedic medicines in improving glycemic control and other vital outcomes in T2DM,^16,17^ concerns persist regarding suboptimal disease management by Ayurvedic practitioners in real-world settings.^13,18????–23^ These concerns arise from the use of untested, ineffective, potentially unsafe, nonstandardized, or low-quality Ayurvedic formulations, which may lead to serious adverse effects, including heavy metal poisoning.^19,23???–27^ Additionally, many practitioners follow unverified claims or adopt a trial-and-error approach to treatment.^22,28^ There are also instances where contradictory lifestyle advice is given, such as recommendations for ghee consumption (clarified butter made from saturated fat).^ 29 ^ Crucial steps in the care pathway, such as detection and management of poorly controlled T2DM and complications, including specialist referrals, are left to individual discretion, leading to unacceptable variations in clinical practice.^13,15,18,19,21?–23^

Evidence-based clinical practice guidelines (EB-CPGs) are statements based on the best available scientific evidence, providing recommendations to support clinicians in decision-making and delivering quality care through effective and safe interventions.^30,31^ In essence, EB-CPGs serve as tools to translate scientific research into clinical practice.^30,31^ While CPGs in Western medicine have been shown to improve T2DM management,^32,33^ no such CPG exists for Ayurvedic practitioners in Nepal. Therefore, an EB-CPG may address existing problems, as its unavailability is a major challenge identified by several stakeholders, including these practitioners.^13,22,34?–36^ To address this gap, we developed an EB-CPG and conducted a feasibility trial with the aim of informing a future definitive cluster randomized controlled trial to assess whether the use of the EB-CPG leads to better management of T2DM compared to usual clinical practice (i.e., without a CPG).^37,38^ The feasibility trial findings will be published elsewhere.^ 39 ^ The aim of this study was to explore the experiences and perspectives of Ayurvedic practitioners and patients regarding the two treatment groups (EB-CPG-based care versus usual clinical practice) and participation in the feasibility trial. The findings will inform refinements to the intervention and the design of a future definitive trial.

Methods

This study employed a constructivist qualitative methodology, prioritizing the understanding of participants’ subjective experiences and perspectives within the healthcare context. Specifically, this approach enabled an in-depth exploration of how Ayurvedic practitioners and patients experienced and perceived the two treatment groups and the feasibility trial.

This qualitative study, conducted as part of the feasibility trial, was coordinated locally by the Kathmandu-based Nepal Health Research Council (NHRC). The trial was conducted in public and private Ayurveda centers (clusters), within and outside Kathmandu Valley. Each center had at least one Ayurvedic practitioner with a minimum of a 5½-year undergraduate medical degree in Ayurveda, registered with the Nepal Ayurveda Medical Council. People from diverse socioeconomic backgrounds visit these centers when they experience disease symptoms, and T2DM is often an incidental finding. When new, treatment-naïve T2DM cases were detected by participating practitioners, these adults were invited to participate in the trial.

In the intervention group, Ayurvedic practitioners managed T2DM using the EB-CPG developed by our team, available in both hard and soft copies.^ 37 ^ Briefly, we developed a high-quality, comprehensive EB-CPG for managing T2DM using a robust methodology that incorporated the best available scientific evidence and involved key stakeholders, including practitioners. EB-CPG covers T2DM diagnosis and treatment targets, lifestyle advice, Ayurvedic antidiabetic medicines, complications screening and management, and specialist referrals for poorly controlled T2DM and its complications. To support its uptake and adherence, practitioners received (i) regular face-to-face and online group training in using the EB-CPG, including individual role-playing and feedback and peer-led sessions to consolidate learning, and (ii) an EB-CPG-based structured booklet for writing case notes. Additionally, an EB-CPG-recommended, standardized, quality-controlled, plant-based Ayurvedic antidiabetic medicine (capsule) was made available at the centers and provided free of charge to patients for the duration of the study. In the control group, usual clinical practice continued, with practitioners managing T2DM without using a CPG.

Semistructured qualitative interviews were conducted with Ayurvedic practitioners and patients in 2023–2024. Intervention and control group practitioners at all trial sites were approached at the end of their participation, either face-to-face or by telephone, by local female multilingual health researchers trained in qualitative research (N.R., Sh.K., or A.A.). Similarly, patients were approached at the end of their trial participation using purposive sampling to ensure diversity in the treatment group (intervention or control), age, gender, and geographical location (inside or outside Kathmandu Valley). The sample size was determined based on recommendations to allow for data saturation.^ 40 ^ To improve the range of perspectives in sampling, we also approached those who declined to participate in the trial or who were recruited but later withdrew. Researchers provided a participant information sheet and a verbal study description and answered any questions. Written informed consent was obtained from those who expressed interest. Participant information sheets and consent forms were available in Nepali and English.

With prior appointments, one-on-one interviews were conducted separately with Ayurvedic practitioners and patients, with data collection from both groups occurring in parallel. Most interviews were conducted by N.R., with some by Sh.K. and A.A. N.R. and A.A. were independent of the trial. Sh.K. was the trial coordinator, which may have influenced data collection. However, her detailed knowledge of the trial was beneficial during interviews, allowing for more specific probing and discussion with participants. The timing and location of interviews (i.e., face-to-face at the center or home or via telephone) were arranged according to the interviewees’ convenience. Interviews were conducted in Nepali, the participants’ preferred language. Predeveloped and pretested interview topic guides were used, and interviews were audio recorded. Field notes were also taken to capture nonverbal cues such as gestures and tone of voice, which might not have been adequately captured through audio recording.

Based on the study’s aim and existing relevant literature, three interview topic guides were developed: one each for completing and noncompleting Ayurvedic practitioners, completing and noncompleting patients, and those who declined trial participation. These guides were refined by the multidisciplinary research team. They covered topics such as provision and receipt of usual clinical care and EB-CPG-based care for managing T2DM, depending on the treatment group, as well as recruitment and participation in the trial. The topic guide for those who declined participation was shorter and focused mainly on exploring their reasons for nonparticipation if they agreed to be interviewed. Guides allowed interviewees to freely express their views, with follow-up questions and probes to capture further detail and develop a deeper understanding of their responses. Topic guides were translated into Nepali by a professional translator based at NHRC and pretested among a small sample of external practitioners and patients to ensure the appropriateness of meaning and understanding.

Professionals at NHRC transcribed the interview recordings verbatim and translated them into English. The qualitative researcher (N.R.) listened to interview recordings multiple times, corrected any inaccuracies in the final transcripts, and anonymized them by redacting identifiable information. Anonymized transcripts were imported into NVivo 14 software for data storage and organization.

Data were analyzed thematically using an inductive approach and the framework method to align with the study’s aim and capture emergent issues raised by the interviewees.^41,42^ Separate but concurrent analyses were performed for Ayurvedic practitioners and patients. Two researchers (K.C. and N.R.) independently familiarized themselves with the interview transcripts through multiple readings and performed line-by-line coding. Preliminary codes were discussed collaboratively, and discrepancies were resolved through consensus rather than formal intercoder reliability statistics, consistent with qualitative best practices. Codes were grouped into categories and then organized into subthemes and overarching themes, refined iteratively as new data emerged, until data saturation was reached—that is, no new themes were identified. Field notes provided additional context and depth to the interpretation of interview data.^ 43 ^ Final themes for both groups were compared to identify similarities and differences.

The analysis was led by K.C., who has extensive experience in qualitative research, is the principal investigator of the trial, and is a trained Ayurvedic practitioner from the neighboring country, India. He is familiar with the context in Nepal, including population characteristics, health-related beliefs and cultural practices, and the structure of the health system. K.C. worked alongside N.R., an independent qualitative researcher based in Nepal, and in consultation with S.M.G., a senior qualitative researcher and methodologist with a background in medical sociology. While K.C.’s dual role may have influenced interpretation, it also ensured that the analysis remained closely aligned with the Nepalese context and the practical realities of Ayurvedic care. Nonattributable verbatim quotes are used to illustrate the core ideas of each theme and subtheme.

This study is reported in accordance with the Consolidated Criteria for Reporting Qualitative Research (COREQ).^ 44 ^

Results

We interviewed 41 individuals (see Table 1): 7 Ayurvedic practitioners from the intervention group and 7 from the control group, 10 patients from the intervention group and 10 from the control group, and a few individuals who declined to participate in the trial or were recruited but later withdrew (1 practitioner and 6 patients). Among the practitioners, six were female, and nine were male. The patients had an average age of 51 years (ranging from 38 to 69 years), with an equal distribution of females and males (13 each) and those residing inside and outside Kathmandu Valley (13 each). The interviews lasted between 20 and 80 min, with an average duration of 45 min.

Table 1.: Individuals interviewed.

See Table 2 for Ayurvedic practitioner and patient themes and subthemes (quotes are in Table 3).

Table 2.: Participant themes and subthemes.

Table 3.: Participant quotes.

Themes common to both Ayurvedic practitioners and patients

Facilitators for patient recruitment in the trial

Ayurvedic practitioners pointed out that the reputation of the Ayurveda centers and high patient flow facilitated patient recruitment in the trial. Offering free tests and medicines encouraged enrollment, while a positive perception of Ayurvedic medicines and assurance of safety reassured patients. Additionally, word-of-mouth referrals from enrolled patients helped boost participation.

Patients reported that they were drawn to the trial by their trust in Ayurvedic medicines, social endorsements, and perceived benefits of free treatment. Many had positive personal experiences with Ayurveda and viewed it as safer and more sustainable than Western medicine. Social influences reinforced this view, and some patients saw their involvement as part of a valuable, potentially impactful initiative. Clarity of the trial and related processes also facilitated patient recruitment, with Ayurvedic practitioners playing a crucial role in helping them understand.

Challenges in patient recruitment in the trial

Ayurvedic practitioners highlighted recruitment challenges, including patient hesitancy and mistrust of research, concerns about continuity of clinical care posttrial, and poor comprehension of the consent process. Gender-based decision-making also influenced participation, with female patients often requiring family consent. Practitioners emphasized the need for regular discussions on recruitment strategies and suggested adjusting the trial eligibility criteria to better suit Ayurvedic treatment capabilities.

Patients, especially those with lower literacy levels, had difficulty understanding the consent process. They often signed the consent form based on their trust and familiarity with Ayurvedic practitioners.

Challenges in providing and receiving usual clinical care

Ayurvedic practitioners highlighted variability and concerns in clinical practice and the patient care pathway, noting the lack of clear lifestyle guidance for patients and limited knowledge of effective and safe Ayurvedic medicines to prescribe. Issues with medicine effectiveness, form, quality, and availability also led to patient dissatisfaction and impacted adherence.

Patients emphasized that they experienced inconsistencies in clinical care, including ambiguous guidance on lifestyle changes and medication use, which left them feeling confused and uncertain. They also highlighted issues with ineffective and poor-quality Ayurvedic formulations in varying forms, further complicated by availability challenges.

Experiences of providing and receiving EB-CPG-based care, which were predominantly positive

Ayurvedic practitioners noted that they received regular training through online and in-person sessions, which helped them confidently advise patients, prescribe EB-CPG-recommended Ayurvedic antidiabetic medicine, and handle complications. Practitioners highlighted that adherence to the EB-CPG minimized errors and ensured consistency in T2DM care, addressing lifestyle modifications, medication, complications, and specialist referrals. The EB-CPG was widely regarded for its structured, comprehensive, and straightforward approach, contrasting with the vagueness of usual clinical practice. It was well-planned, easy to follow, and helped refresh practitioners’ knowledge. EB-CPG made it easier to explain treatment and build trust with patients by improving patient care and enhancing communication. Several practitioners reported that EB-CPG became an integral part of their routine clinical practice posttrial, and they continued delivering EB-CPG-based care. Practitioners observed that the structured booklet for writing case notes provided a clear, sequenced format aligned with the EB-CPG, supporting standardized documentation in patient care. Some practitioners suggested a written booklet for patients to support EB-CPG-based lifestyle advice. Practitioners noted that several patients strongly desired to continue EB-CPG-recommended Ayurvedic antidiabetic medicine after the trial, but the lack of a continuity plan raised concerns about sustaining their trust.

Patients highlighted that they valued respectful interactions with Ayurvedic practitioners and clear guidance on lifestyle and medication. Regular health monitoring helped them feel supported. Several patients reported adherence to EB-CPG-based lifestyle advice and compliance with EB-CPG-recommended Ayurvedic antidiabetic medicine. However, some faced routine medication adherence challenges, such as occasional forgetfulness or frustration with taking multiple medicines. Patients observed notable health benefits from EB-CPG-based Ayurvedic treatment without side effects, strengthening their trust in Ayurveda as a safe approach to health. Some expressed hope for a similar approach to be applied to other health conditions. Patients noted that the monthly supply of EB-CPG-recommended Ayurvedic antidiabetic medicine was generally smooth and met their needs, though busy schedules sometimes disrupted timely pickup. They appreciated Ayurveda centers’ reminders and support, which helped maintain consistent adherence without stockpiling. Some patients expressed a desire for a written booklet to support EB-CPG-based lifestyle advice, as it would provide a helpful reference for remembering advice. As the trial ended, several patients expressed concerns about losing access to EB-CPG-recommended Ayurvedic antidiabetic medicine that had benefited them, with many hoping for continued support to sustain their health improvements.

Ease and difficulties of monthly follow-ups

Ayurvedic practitioners highlighted the importance of trust-building and patient prioritization in improving follow-up adherence. Regular follow-ups, timely medication, and monthly blood tests helped maintain patient engagement. However, challenges arose due to scheduling difficulties, long travel distances for some patients, and delays from local events. While regular communication could reduce dropouts, it was often impractical for practitioners to coordinate follow-ups due to their busy clinical schedules.

Patients highlighted that monthly follow-ups were manageable for those nearby and familiar with Ayurveda centers. However, others faced logistical and health-related challenges, particularly when balancing travel, health conditions, and household duties. Supportive measures from centers, like scheduling flexibility and reminders, helped but didn’t fully resolve these difficulties for everyone. Some had poor comprehension of the processes, particularly around blood tests, indicating areas for clearer communication.

Pros and cons of maintaining patient diaries for assessing compliance with EB-CPG-recommended Ayurvedic antidiabetic medicine

Some Ayurvedic practitioners found patient diaries helpful in tracking medication adherence. However, others noted challenges in patient compliance, especially among those with low literacy or limited understanding of the diary’s purpose. For data accuracy, some patients forgot or misreported entries, prompting practitioners to monitor pill counts and engage directly with patients to verify adherence.

Patients pointed out that keeping a diary was easy for some but challenging for others due to busy schedules or limited literacy. Forgetfulness sometimes led to delayed entries, and logistical issues, such as diary size, space, or availability, affected adherence tracking. Maintaining the diary was stressful for them.

Themes specific to Ayurvedic practitioners

Ayurvedic practitioners serve diverse populations

Ayurvedic practitioners mentioned that they treat patients from diverse socioeconomic backgrounds, with a broad age range, including young adults and older individuals.

Patients’ motivations for choosing Ayurveda over Western medicine

Ayurvedic practitioners noted that many patients prefer Ayurvedic treatments over Western medicine options, believing they have no side effects. Positive experiences from others drive further interest. Additionally, patients on Western medicine often seek Ayurveda due to uncontrolled blood glucose, fear of insulin injections, and high treatment costs.

Ayurvedic practitioners’ motivations for participating in the trial

Ayurvedic practitioners mentioned that they were motivated to join the trial because they valued evidence-based clinical practice and saw the trial as beneficial both for the advancement of Ayurveda as a traditional medical system and for their own professional development. Some were drawn by their growing interest in research, particularly international studies on noncommunicable diseases, including diabetes. They felt research was needed to improve disease management using Ayurveda, particularly around treatment protocols (EB-CPGs). They also recognized the historical significance of the trial in Nepal, seeing it as an opportunity to establish solid evidence to attract and assure patients of Ayurveda’s benefits.

Balancing clinical duties with the trial demands

Several Ayurvedic practitioners faced challenges balancing their clinical duties with the trial demands, often viewing research as an added workload. High patient volumes required them to work longer hours or forgo personal time, though they found value in the experience. Some noted that additional staff support could have eased the burden.

Confusion regarding roles and responsibilities in the trial

Many Ayurvedic practitioners experienced confusion regarding trial roles and responsibilities, both among themselves and when contacting the study coordination team. This underscores the need for clearer communication about roles from the outset and a more substantial commitment to responsibilities throughout the trial.

Issues in understanding the trial processes and documentation

Several Ayurvedic practitioners found trial processes and documentation challenging, citing confusion around protocols and the complexity of paperwork. While initial training helped clarify some aspects, they still struggled to explain the research process to patients and felt that lengthy documentation was an additional burden. This highlights the need for regular, practice-oriented training, and reduced paperwork to improve trial efficiency.

Issues in the trial support and communication

Ayurvedic practitioners appreciated the support and communication from the study coordination team, but several others also noted that the support and communication were inadequate. They highlighted the need for frequent follow-ups and monitoring, especially for those with less research experience, to maintain consistent support and communication throughout the trial.

Issues in coordination with the trial data collectors/outcome assessors

Ayurvedic practitioners noted that while data collectors/outcome assessors were considerate of patients’ availability, coordinating timing with them proved challenging due to their preexisting schedules.

Trial-related financial and other resource issues

Several Ayurvedic practitioners faced financial and other resource challenges in the trial, including delayed payments, out-of-pocket expenses due to billing procedures, and delays in receiving trial-related materials.

Discussion

This qualitative study explored the experiences and perspectives of Ayurvedic practitioners and patients in Nepal concerning two treatment groups for T2DM management—EB-CPG-based care versus usual clinical practice—and their participation in the feasibility trial. Common themes identified across both groups included facilitators and challenges in patient recruitment for the trial, challenges in providing and receiving usual clinical care, experiences of providing and receiving EB-CPG-based care (which were predominantly positive), ease and challenges of monthly follow-ups, and pros and cons of maintaining patient diaries to assess compliance with EB-CPG-recommended Ayurvedic antidiabetic medicine. Themes specific to practitioners included the diverse populations they serve; patients’ motivations for choosing Ayurveda over Western medicine; their motivations for participating in the trial; balancing clinical duties with the trial demands; confusion about trial roles and responsibilities; and other trial-related issues such as understanding processes and documentation, support and communication, coordination with data collectors, and finances and other resources.

Diverse populations served by Ayurvedic practitioners in South Asia and patients’ motivations for choosing Ayurveda over Western medicine are well documented.^10????–15^ The same is true for challenges encountered in routine Ayurvedic practice.^13,15,18??????????–29^ In this study, practitioners similarly reported inconsistencies in clinical practice, including unclear lifestyle recommendations and limited knowledge of effective and safe Ayurvedic medicines. Issues with Ayurvedic medicine quality, effectiveness, form, and availability contributed to patient dissatisfaction and poor adherence. Patients echoed these concerns, citing confusion from inconsistent clinical care, vague lifestyle advice, and unclear medication instructions, as well as challenges accessing quality and effective Ayurvedic medicines.

EB-CPGs have demonstrated the potential to enhance care quality and health outcomes, as shown in multiple systematic reviews.^45??–48^ Several countries—particularly high-income nations—have successfully implemented EB-CPGs, with similar examples now emerging from low- and middle-income countries (LMICs).^ 49 ^ Ours is the first documented study to explore the use of an EB-CPG in Ayurveda in general and for the management of T2DM in particular.^ 50 ^ This qualitative study provided rich insights into the acceptability, perceived impact, challenges, and future scope of implementing an EB-CPG in routine Ayurvedic practice.

Ayurvedic practitioners valued the structured, comprehensive, and clear nature of the EB-CPG and its supporting resources, such as the training provided and the structured booklet for recording case notes. We employed a range of strategies to promote uptake and adherence to the EB-CPG, consistent with findings from an umbrella review on effective implementation strategies.^ 49 ^ This is crucial because developing and disseminating EB-CPGs alone is insufficient to achieve meaningful improvements in practice; success depends on active, context-sensitive implementation tailored to specific clinical settings.^45???–49,51??–54^ Practitioners emphasized that adherence to the EB-CPG minimized errors and ensured consistency in T2DM management and adherence to the care pathway. Although the primary focus of this study was not on practitioners’ soft skills, both practitioners and patients observed positive changes in this area linked to the implementation of the EB-CPG. Soft skills—such as confident communication and the ability to deliver compassionate, patient-centered care—are essential for improving health outcomes and fostering trust.^55,56^ Patients also appreciated care provided through the EB-CPG-based approach and reported perceived health benefits from adherence to practitioners’ advice based on the EB-CPG.

Our study findings on care processes and patient outcomes are crucial for assessing improvements in care quality, as emphasized in the Donabedian model.^ 57 ^ Another important dimension—the structural aspect—was largely addressed through the resources provided during the trial. Although this study was not a drug trial and we could not continue providing access to the same EB-CPG-recommended Ayurvedic antidiabetic medicine posttrial (as requested by several intervention-group patients wishing to sustain their health improvements), Ayurvedic practitioners were supported in transitioning patients to available healthcare facilities and medicines. This approach ensures ethical clinical research practices and helps maintain public trust.^ 58 ^ Several practitioners reported that the EB-CPG became an integral part of their routine clinical practice posttrial and that they continued delivering EB-CPG-based care. Some practitioners and patients suggested developing a written booklet to support EB-CPG-based lifestyle guidance, and several recommended applying a similar EB-CPG approach to manage other health conditions.

Several systematic reviews have synthesized trial conduct-related issues, including participant recruitment and retention, and suggested potential solutions to address these challenges.^59??????–66^ Our study findings align with those of these reviews, indicating that these are global challenges in trial conduct, particularly in LMICs like Nepal. Our previous trial-related work in India, a neighboring LMIC, also demonstrated similar facilitators and challenges.^67?–69^ Although our participating Ayurvedic practitioners were motivated and interested in research and evidence-based healthcare, most of our sites (Ayurveda centers) had little to no experience with research and were new to clinical trials. Additionally, their clinical workload was high. Therefore, there is a need to provide them with continuous, high-quality trial-related training and support from the study coordination team.^ 70 ^ Simplifying trial conduct, particularly reducing trial-related workload, will improve trial efficiency—for example, by minimizing nonessential paperwork.^71,72^

In this study, Ayurvedic practitioners suggested adjusting the trial eligibility criteria in the definitive trial to better align with Ayurvedic treatment capabilities, specifically by increasing the upper glycated hemoglobin (HbA1c) limit from <9% (initially, it was <7.5%) to 10%. As a feasibility trial, we were extra cautious, setting a lower cut-off arbitrarily for patient safety, without specific scientific evidence to support it. Although our definitive trial will not test a new drug, it will be a pragmatic study addressing a real-world issue, where people with high blood glucose levels continue to prefer Ayurveda, as observed in our feasibility trial. Consequently, in the definitive trial, patients in the control group will continue to receive usual clinical care, including commonly prescribed Ayurvedic formulations, while those in the intervention group will receive EB-CPG-based care, including EB-CPG-recommended Ayurvedic antidiabetic medicine. Importantly, we will have a robust trial conduct and governance structure.

Another major challenge both Ayurvedic practitioners and patients reported was maintaining patient diaries to assess medication compliance. Given that the definitive trial will be pragmatic on disease management and will not test a new drug, in which medication compliance is assessed using patient diaries, less burdensome methods of assessing adherence could be used.^ 73 ^ These alternatives would improve the trial experience for everyone involved, such as using the Adherence to Refills and Medications Scale.^73?–75^ A similar challenge was posed by monthly follow-ups. In the definitive trial, long-term follow-ups will be conducted, which are more important in this chronic condition than monthly follow-ups.^ 2 ^ That said, we will have the process in place for reporting adverse events and serious adverse events during nonscheduled visits.

To our knowledge, this is the first qualitative study to explore using an innovative approach in Ayurvedic management of T2DM, capturing the experiences and perspectives of both healthcare providers and a diverse range of patients. Additionally, trial-based qualitative evaluations remain extremely limited in Nepal. Regarding generalizability, our qualitative sample was drawn from the feasibility trial population, not the broader national population. For instance, we interviewed all Ayurvedic practitioners who participated in the trial and 25 of the 121 enrolled patients. While the study does not aim for statistical generalizability, it is analytically generalizable to the feasibility trial context. Although face-to-face interviews often generate richer data due to effective icebreaking and the ability to observe body language and facial expressions, several interviews were conducted by telephone to address accessibility issues, particularly with participants outside Kathmandu Valley. Evidence suggests that the quality of data collected via face-to-face and telephone interviews is not necessarily different.^76,77^ Although interviewers made efforts to build rapport with participants before interviews, some telephone interviews were shorter, especially with those who had declined to participate in the trial or who were recruited but later withdrew. Reaching out to these individuals proved challenging, and as a result, only a small number of them were interviewed. There are potential limitations related to recall and social desirability bias. Since interviews were conducted at the end of participants’ involvement in the trial, some individuals may not have recalled their experiences in full detail or with complete accuracy. Additionally, both patients and Ayurvedic practitioners may have provided responses they believed were expected or viewed favorably by the research team, particularly regarding the intervention or the trial overall. We sought to minimize these biases by using open-ended, nonleading questions and trained interviewers and by assuring participants that their responses would remain confidential and would not affect their care or professional roles.

In conclusion, the EB-CPG-based approach for managing T2DM by Ayurvedic practitioners in Nepal was well received and perceived as more beneficial than usual clinical practice. Trial experiences and perspectives were largely positive; however, several challenges related to trial conduct should be addressed in future studies, including the definitive cluster trial.